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对患有交界性和轻度核异质的女性进行高危型人乳头瘤病毒检测:长期随访数据及临床意义

High-risk HPV testing in women with borderline and mild dyskaryosis: long-term follow-up data and clinical relevance.

作者信息

Denise Zielinski G, Snijders P J, Rozendaal L, Voorhorst F J, Runsink A P, de Schipper F A, Meijer C J

机构信息

Department of Pathology, University Hospital Vrije Universiteit, De Boelelaan 1117, 1081 HV Amsterdam, The Netherlands.

出版信息

J Pathol. 2001 Oct;195(3):300-6. doi: 10.1002/path.981.

Abstract

In The Netherlands and most other European countries, women with two serial cervical smears with borderline or mild dyskaryosis (BMD) within 6 months are referred for colposcopy-directed biopsies. Only about 10% of these women have high-grade cervical intraepithelial neoplasia (CIN). This study therefore investigated whether human papillomavirus (HPV) testing could identify which women with smears read as BMD are most likely to have high-grade CIN, either at referral or during follow-up and the relationship was determined between clearance of high-risk HPV and regression of abnormal cytology. Women with smears read as BMD (n=278) were referred to the gynaecologist for colposcopy. They were subdivided into two groups; group A comprised women with a single smear (n=172) and group B women with two sequential smears (n=106) read as BMD before referral. High-risk HPV detection with Hybrid Capture II (HC II) was performed on a cervical scrape taken at the first visit before colposcopy (i.e. baseline smear) and during follow-up. Biopsies were taken when lesions suspected for CIN were seen at colposcopy. High-risk HPV DNA was present in the baseline smears of 126 (45.0%) women; 26 (20.6%) of them had histologically confirmed CIN 2/3 at the first visit and another 14 (11.1%) during follow-up. Only one of the 152 women (0.7%) with a negative high-risk HPV test had a CIN 2 lesion at the first visit and no CIN lesions were detected during follow-up of these women. After exclusion of women who were treated for prevalent high-grade CIN, the median follow-up times were 1.3 years (range 0.0-4.3 years) and 1.6 years (range 0.0-4.5 years) for women with HPV-negative and HPV-positive baseline smears, respectively. The sensitivity of a positive high-risk HPV test for CIN 2/3 at the first visit was 96.3%, the specificity 60.2%, the positive predictive value 20.6%, and the negative predictive value 99.3%. These values did not change markedly when stratified for group A or group B. Thus, a high-risk HPV positive test was strongly associated with the presence at the first visit and the development of CIN 2/3 lesions during follow-up. Moreover, regression of abnormal cytology in women with a positive high-risk HPV test at baseline was strongly associated with viral clearance and occurred 0.3 years (range -1.2 to 1.7 years) later than HPV clearance. This study establishes the value of a high-risk HPV positive test for women at risk of high-grade CIN, with virtually no risk for missing CIN 2/3. Addition of a test on high-risk HPV in women with BMD could prevent 55% of the referrals and/or repeat smears.

摘要

在荷兰和大多数其他欧洲国家,6个月内连续两次宫颈涂片检查结果为边界性或轻度核异质(BMD)的女性会被转诊进行阴道镜引导下活检。这些女性中只有约10%患有高级别宫颈上皮内瘤变(CIN)。因此,本研究调查了人乳头瘤病毒(HPV)检测能否识别出哪些涂片结果为BMD的女性最有可能患有高级别CIN,无论是在转诊时还是随访期间,并确定了高危型HPV清除与异常细胞学消退之间的关系。涂片结果为BMD的女性(n = 278)被转诊至妇科医生处进行阴道镜检查。她们被分为两组;A组包括单次涂片的女性(n = 172),B组包括转诊前连续两次涂片结果为BMD的女性(n = 106)。在阴道镜检查前的首次就诊时(即基线涂片)以及随访期间,对宫颈刮片进行杂交捕获二代(HC II)高危型HPV检测。当在阴道镜检查中发现疑似CIN的病变时进行活检。126名(45.0%)女性的基线涂片中存在高危型HPV DNA;其中26名(20.6%)在首次就诊时经组织学确诊为CIN 2/3,另外14名(11.1%)在随访期间确诊。152名高危型HPV检测阴性的女性中,只有1名(0.7%)在首次就诊时患有CIN 2病变,且在这些女性的随访期间未检测到CIN病变。在排除接受过现有高级别CIN治疗的女性后,HPV阴性和HPV阳性基线涂片女性的中位随访时间分别为1.3年(范围0.0 - 4.3年)和1.6年(范围0.0 - 4.5年)。首次就诊时高危型HPV检测阳性对CIN 2/3的敏感性为96.3%,特异性为60.2%,阳性预测值为20.6%,阴性预测值为99.3%。按A组或B组分层时,这些值没有明显变化。因此,高危型HPV检测阳性与首次就诊时的存在以及随访期间CIN 2/3病变的发展密切相关。此外,基线高危型HPV检测阳性的女性异常细胞学的消退与病毒清除密切相关,且比HPV清除晚0.3年(范围 -1.2至1.7年)。本研究确定了高危型HPV检测阳性对有高级别CIN风险女性的价值,几乎不存在漏诊CIN 2/3的风险。对BMD女性增加高危型HPV检测可避免55%的转诊和/或重复涂片检查。

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